Ascendis Pharma A/S (ASND) Monday said it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH to treat adults with growth hormone deficiency.
TransCon hGH is marketed as Skytrofa in the U.S. for pediatric growth hormone deficiency.
The submission is based on positive results from foresiGHt, a Phase 3 study that compared the efficacy and safety of TransCon hGH in adults with growth hormone deficiency.
TransCon hGH demonstrated superiority on its primary efficacy and key secondary efficacy endpoints at Week 38, with TransCon hGH-treated patients showing a statistically significant reduction from baseline in trunk fat and increase in total body lean mass at Week 38 compared to placebo, the company said in a statement.
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